How many documented information does ISO 9001:2015 required?

You are required to maintain mandatory 5 documented information and 22 mandatory records for meeting ISO 9001:2015 requirements.


What are the 5 mandatory documented information ?

  1. Scope of the QMS (4.3)

  2. Operation of Processes (4.4.2a)

  3. Quality Policy (5.2.2)

  4. Quality Objectives (6.2.1)

  5. Control of production and service provision (8.5.1)


What are the 22 mandatory records?

  1. Operations of Processes (4.4.2b)

  2. Monitoring and Measurement Resources ( 7.1.5.1)

  3. Measurement Traceability (7.1.5.2)

  4. Competence (7.2)

  5. Operational Planning and control (8.1)

  6. Requirements Review (8.3)

  7. Design and Development Planning (8.3.2)

  8. Design and Development Inputs (8.3.3)

  9. Design and Development Controls (8.3.4)

  10. Design and Development Outputs (8.3.5)

  11. Design and Development Changes (8.3.6)

  12. External Provided Products and Services (8.4.1)

  13. Control of production and service provision (8.5.1)

  14. Traceability (8.5.2)

  15. Property belonging to customers or external providers (8.5.3)

  16. Control of Changes (8.5.6)

  17. Release of Products and Services (8.6)

  18. Control of nonconforming outputs (8.7.2)

  19. Monitoring, measurement, analysis and evaluation - General (9.1.1)

  20. internal Audit (9.2.2)

  21. Management Review (9.3.3)

  22. Nonconformity and corrective action (10.2.2)